Fecal sampling device and method

ABSTRACT

A collection device for use in connection with off-device testing of collected samples. The device includes a first panel having one or more apertures for receiving samples, a second panel opposite the first panel, and a removable tab having a first portion and a second portion. The first portion is aligned with at least one of apertures on the first panel and constructed such that depositing the sample through the at least one aperture causes the sample to be directly deposited on the first portion of the tab, and the second portion includes a sample-free grasping area accessible from an exterior of the device for removing the tab. A method of obtaining a sample is also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/900,245, filed Oct. 7, 2010, which is a continuation of U.S.application Ser. No. 11/137,817, filed May 24, 2005, now U.S. Pat. No.7,833,794, which is a continuation-in-part of U.S. application Ser. No.10/896,607, filed Jul. 22, 2004, now U.S. Pat. No. 7,427,505, whichclaims the benefit of U.S. Provisional Application No. 60/610,345, filedSep. 16, 2004, the entire disclosure of each of which is expresslyincorporated by reference herein.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates, generally, to specimen collection andmore particularly, a device for collecting and determining the presenceof occult blood in fecal matter, a method of testing using such a deviceand a test kit containing such a device.

Description of Related Art.

Over 100,000 persons per year in the United States are afflicted withcancer of the colon and rectum. When the number of colon/rectal cancersoccurring each year is combined with the number of cancers occurring inother digestive organs, including the esophagus and stomach, suchcancers of the digestive system account for more occurrences of cancerthan any other single form of the disease. Contrary to many other formsof cancer, early diagnosis and treatment of digestive tract cancer doesresult in a cure rate of 80% to 90%. If, however, the disease is notdetected until the later stages, the cure rate drops significantly.Thus, early detection of the disease is important to successfultreatment of digestive tract cancer.

Most, but not all, cancers of the digestive tract bleed to a certainextent. This blood is deposited on and in fecal matter excreted from thedigestive system. The presence of blood in fecal matter is not normallydetected, however, until gross bleeding, that is, blood visible to thenaked eye, occurs. Gross bleeding, however, is symptomatic of advancedcancers.

Digestive tract cancers in the early stages, including pre-cancerouspolyps, also tend to bleed, giving rise to occult (hidden) blood in thefecal matter. Other pathological conditions, such as Crohn's disease anddiverticulitis, can also give rise to the presence of occult blood inthe fecal matter.

It is known that because of the relatively high fat content of fecalmatter, blood, when present, is not distributed uniformly throughout it.For this reason, obtaining multiple samples from different areas of eachbowel movement is desirable; but even a single positive test from anypart of the feces should be considered a positive result.

Accordingly, test equipment and test procedures have been developed foruse by physicians in testing for the presence of occult blood in fecalmatter. One of the most successful tests is manufactured and sold bySmithKline Diagnostics of Sunnyvale, Calif. under the trademarkHEMOCCULT and disclosed in Pagano U.S. Pat. No. 3,996,006, which isincorporated herein by reference in its entirety. In general, the Paganotest employs an absorbent paper impregnated with a guaiac reagent andencased in a special test slide having openable flaps on both sides ofthe test slide. To use the Pagano test slide, a sample of fecal matteris smeared onto the guaiac impregnated paper by opening the panel on oneside of the test slide. Thereafter, the panel is closed. The panel onthe opposite side of the test slide is then opened and a nonaqueousdeveloping solution is applied to the guaiac impregnated paper. Ifoccult blood is present in the fecal matter smeared on the opposite sideof the paper, the guaiac reaction will dye the paper blue, providing apositive indication of the presence of blood in the fecal matter.

A drawback of this type of test is that a high percentage of falsepositives are obtained from patients who in fact do not have a cancer orother condition for which occult blood is symptomatic. For example,certain foods, such as rare red meat and peroxidase enzymes as presentin certain foods, such as horseradish, broccoli and cantaloupe, cancause a false positive result.

To cut down on false positives, physicians place patients on specificdiets designed to restrict the intake of animal proteins and othersources of false positives. Despite these efforts, large numbers offalse positives still occur, as compliance with the restricted diet isunreliable. A false positive result in the test often results inexpensive follow-up testing of patients who in fact have simply consumeda lot of meat or other undesirable foods just prior to the test.

A specific test for human hemoglobin has been devised. This test,offered by SmithKline Diagnostics under the tradename HEMESELECT,theoretically registers only human hemoglobin and not animal blood frommeat or other agents, and therefore, theoretically does not require thepatient to be on a special diet. While the hemoglobin test has theadvantage over guaiac tests of registering only human hemoglobin, thehemoglobin test is expensive for a screening test and requires speciallytrained individuals to perform and read the test. Furthermore,hemoglobin tests are typically very sensitive, capable of detecting aslittle as 0.3 micrograms of blood, which is in excess of what a healthynormal person loses in fecal matter daily. Thus, because even healthyindividuals lose a small amount of blood, which can be detected, apositive result may itself be a false positive leading to furthercostly, unnecessary test and procedures.

A need therefore exists for a relatively inexpensive test that has aminimal incidence of false positives and minimal manipulation of thespecimen.

SUMMARY OF THE INVENTION

Embodiments of the present invention satisfy the foregoing, as well asother, needs. In accordance with one embodiment of the presentinvention, there is provided a specimen testing device comprising: afirst panel comprising a first aperture for receiving a first specimenand a second aperture for receiving a second specimen; a second panel; asheet disposed between the first and second panels for receiving atleast the first specimen through the first aperture, wherein the sheetincludes a test area having a reagent for possible reaction to the firstspecimen as part of a primary test procedure; and a removable tab atleast partially aligned with the second aperture for receiving thesecond specimen, the removable tab accessible from an exterior of thedevice and available for use in a secondary test procedure. In certainembodiments, the removable tab is formed integrally from the secondpanel.

In accordance with another embodiment of the present invention, there isprovided a specimen testing device comprising: a first panel comprisinga single aperture for receiving a first specimen and a second specimenfrom the single sample of a bowel movement smeared over the singleaperture; a second panel; a sheet disposed between the first and secondpanels for receiving at least the first specimen through the singleaperture, wherein the sheet includes a test area having a reagent forpossible reaction to the first specimen as part of a primary testprocedure; and a removable tab removable from an exterior surface of thefirst panel, wherein the removable tab is accessible from an exterior ofthe device, is available for use in a secondary test procedure andobscures a portion of the single aperture.

In accordance with another embodiment of the present invention, there isprovided a method of testing for the presence of blood in fecal matter,the method comprising obtaining a primary specimen from a first area ofthe fecal matter on a testing device; obtaining a secondary specimenfrom the first area of the fecal matter on a removable tab of thetesting device, wherein the secondary specimen is a portion of theprimary specimen; testing the primary specimen for the presence of bloodusing a non-specific test; if the testing of the primary sampleindicates the presence of blood, removing the removable tab, theremovable tab having at least a portion of the secondary specimen; andtesting the secondary specimen for the presence of blood using aspecific test, wherein the testing of the secondary specimen facilitateseither identification of a false positive result from the testing of theprimary specimen with the non-specific test or confirmation of positiveresult from the testing of the primary specimen.

In yet another embodiment of the present invention there is provided atest kit including a specimen testing device described above; reagentsfor performing a primary test on specimens received into the firstaperture of the first panel; and reagents for performing a secondarytest on specimens received into the second aperture of the first panel.

In yet another embodiment, the device comprises a well for receiving aprimary portion of a specimen for use in a primary test; a removable tabat least partially obscuring the well, the tab receiving a secondaryportion of the specimen, the primary portion and secondary portioncapable of being from a single smear of the specimen for use in asecondary test.

In accordance with another embodiment of the present invention, there isprovided a fecal sampling device comprising: a first panel comprisingmultiple apertures for receiving samples; and a second panel having aremovable tab, the removable tab aligned with the apertures when thedevice is assembled such that depositing of samples through theapertures deposits the sample on the removable tab.

In yet another embodiment there is provided a fecal sampling devicecomprising: a first panel comprising multiple apertures for receivingsamples, wherein the apertures are positioned off center in the firstpanel, away from an edge of the first panel, and the tab includes anenlarged grasping area adjacent to the edge; and a second panel having aremovable tab, the removable tab aligned with the apertures when thedevice is assembled such that depositing of samples through theapertures deposits the sample on the removable tab. In certainembodiments the tabs need not be positioned off center in the firstpanel.

In another embodiment of the present invention there is provided amethod of collecting a fecal sample using a fecal sampling devicescomprising the steps: applying the sample through the multiple aperturesonto the removable tab; and removing the removable tab, therebycollecting the sample.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will now be described with reference to the accompanyingdrawings, in which:

FIG. 1 is a front perspective view of a device according to oneembodiment of the invention showing the first panel with three covers inthe open position;

FIG. 2 is a rear perspective view of the device of FIG. 1 showing thesecond panel having one tab in an open position;

FIG. 3 is a perspective view of an absorbent sheet according to oneembodiment of the present invention;

FIG. 4 is a perspective view of the device of FIGS. 1 and 2 in anun-assembled state;

FIG. 5 is a perspective view of an absorbent sheet according to analternate embodiment of the invention;

FIG. 6 a is a perspective view of a device according to anotherembodiment of the invention showing the second panel containing circulartabs;

FIG. 6 b is a sectional view of the second panel of FIG. 7 a taken alongline A-A showing the circular tab attached to the second panel;

FIGS. 7 a-c are perspective views of alternate embodiments of thepresent invention utilizing the same well for both primary and secondaryspecimens; and

FIG. 8 is a perspective view of a sampling device in an un-assembledstate according to an alternate embodiment of the invention.

DETAILED DESCRIPTION

Referring to FIGS. 1-4, a fecal occult blood testing device 2 accordingto one embodiment of the invention, is shown. The device 2 generallyincludes three test areas 100, 102, 104 and is formed of a first panel 4and a second panel 6, with an absorbent sheet 8 disposed between thefirst and second panels 4, 6, on which a specimen is placed.

Each test area, 100, 102, 104 is configured to receive both primarysamples and secondary samples. The first test area 100 includes twoapertures 10, 12 in panel 4 for receiving primary samples and twoapertures 22, 24 for receiving secondary samples. Similarly, the secondtest area 102 includes apertures for primary samples 14, 16 andapertures for secondary samples 26, 28, and the third test area 104includes primary 18, 20 and secondary 30, 32 sample apertures. Accordingto the present embodiment, the shapes of the apertures on panel 4 caninclude, but are not limited to an oval, circle, square or rectangle.

Each of the three areas 100, 102, 104 also has a cover 40, 42, 44,respectively, thereto along a fold line extending transversely of thelongitudinal axis L. Each cover 40, 42 and 44 is engageable with acorresponding flap formed by arcuate slit 34, 36, 38, respectively,which is used to maintain the covers in a closed position, after thesamples are obtained.

As shown in FIG. 2, each of the three test areas 100, 102 and 104further includes, on the second panel 6, perforated tabs, each of whichaligns with a corresponding aperture for a secondary sample. Morespecifically, test area 100 includes perforated tabs 62 and 64 alignedwith apertures 22 and 24, respectively; in test area 102, tabs 66 and 68align with apertures 26 and 28, respectively; and in test area 104, tabs70 and 72 align with apertures 30 and 32, respectively.

Also shown in FIG. 2, in addition to the perforated tabs 62, 64, 66, 68,70 and 72, each of which aligns with a corresponding aperture for asecondary sample, each test area 100, 102, 104 includes a flap which isaligned with the primary test area apertures of the first panel 4. Morespecifically, test area 100 includes a flap 74 aligned with bothapertures 10 and 12 in such a way that opening of flap 74 exposes theprimary test area of sheet 8, which is aligned with both apertures 10and 12. Test area 102 includes a flap 76 aligned with both apertures 14and 16 and test area 104 includes a flap 78 aligned with both apertures18 and 20. As discussed below, the flaps 74, 76, 78 are opened to allowa reagent to be placed on the filter paper 8 when performing thenon-specific test.

As described below, each tab 62, 64, 66, 68, 70 and 72 initially ismaintained in a closed position, but may be opened along theperforations (in the present embodiment, along three sides althoughother configurations may be used) and separated from the second panel 6.

In the present embodiment, as illustrated in FIG. 3, the sheet 8 is asingle piece of filter paper generally dimensioned as the second panel6. In alternative embodiments, however, the sheet is dimensioned only tocover the primary sample apertures, where the sheet is impregnated withguaiac resin. Sheet 8 has six rectangular (although other shapes may beused) perforated zones 120, 122, 124, 126, 128 and 130, which, when thedevice 2 is assembled, are positioned in such a way as to align with andbe between apertures 22, 24, 26, 28, 30 and 32, respectively, of panel 4and tabs 62, 64, 66, 68, 70 and 72, respectively, of panel 6. Moreover,the zones 120, 122, 124, 126, 128 and 130 have perforations to enablethe zones 120, 122, 124, 126, 128 and 130 to be removed from the sheet 8along with the corresponding tabs 62, 64, 66, 68, 70 and 72, asdescribed in more detail below. In alternate embodiments, the zones arenot perforated, but rather simply tear away from the rest of the sheet.

Tabs 62, 64, 66, 68, 70 and 72 are aligned in such a way that theperforated zones 120, 122, 124, 126, 128 and 130 containing thespecimens only come into contact with a portion of the tabs. The portionof the tab that does not come into contact with the specimen (e.g. 63)is used to pull the tab away from the device. In this way, physicalcontact between the tester and the specimen is prevented, therebydecreasing the chance of contamination of the specimen.

In certain embodiments, the tabs 62, 64, 66, 68, 70 and 72 have a spotof adhesive to allow the zones 120, 122, 124, 126, 128 and 130 to adherethereto.

In certain embodiments, sheet 8 is made of an absorbent material, and istypically filter paper impregnated with a reagent which will react withhemoglobin components from blood and a peroxide solution to form acolored compound. Examples of suitable reagents are guaiac, tetraethylbenzidene, orthotoluidine and other similar chromogens. In theembodiment illustrated herein, the reagent impregnated in sheet 8 isguaiac. Here, the areas corresponding to the primary sample apertures10, 12, 14, 16, 18 and 20 are impregnated with the reagent and the areascorresponding to the secondary sample apertures 22, 24, 26, 28, 30 and32 are not impregnated with reagent. It is possible, however, for allsub-sections to be impregnated with reagent provided impregnation doesnot adversely affect any subsequent testing which might be conductedusing the tab (secondary sample) areas.

To reduce risk of cross-contamination, prevent or minimize possibleleakage of developing solution and to ease separation of the three testareas 100, 102, 104 on sheet 8, the test areas 100, 102, 104 areseparated from each other by dividing regions 80 and 82, and the primarysample areas are separated from the secondary sample areas by dividingregion 84, all of which may comprise a hydrophobic material, for examplewax, glue or other suitable material. Alternatively, the primary samplearea and the secondary sample area may be comprised of separate piecesof filter paper separated by a hydrophobic barrier. In still anotherembodiment, the samples are separated by a crimp or other physicalbarrier comprised of one or more of the panels themselves. As will beunderstood, the degree to which the areas are separated is dependentupon the tendency of the secondary testing procedure to be adverselyaffected by contamination.

As illustrated in FIG. 4, the panels 4, 6 and covers 40, 42, 44, can beformed of a single sheet of paper, cardboard or other suitable material,in which the apertures, slits, tabs and perforations are die-cut. Thedevice 2 is assembled by overlaying panel 4 on to panel 6 with the sheet8 therebetween. The assembly is held together with a suitable glue oradhesive. Although not required, to minimize sticking of the covers tothe specimen, the panels 4 and 6 are provided on their inner surfaceswith a layer of non-stick material, typically a wax layer although othermaterials may be used. In this way, the perforated zones 120, 122, 124,126, 128 and 130 of sheet 8 carrying the secondary specimen can beremoved without them sticking to the inner surfaces of the covers on thefirst and second panels.

The covers 40, 42 and 44 for first panel 4 may be provided withappropriate printed matter to assist the patient, physician and/orlaboratory. For example, the patient's name, address and instructions onhow to use the device may be printed on the covers 40, 42 and 44. Suchinstructions may include instructing the patient to apply a specimenfrom the same areas of the fecal matter, or even the same smear, in eachof the primary sample well and corresponding sample well. Blood is notuniformly distributed throughout the fecal matter because of the highfat content of the fecal matter. As discussed below, using the samesample in both the primary and secondary sample wells accounts for thisand allows the secondary specimen to be used in a confirmatory testingprocedure. Other printed matter that may also be provided on the firstpanel 4 includes for example, the sample number and the test to beperformed (e.g., primary analysis or secondary analysis). Printed mattermay also be provided on the second panel 6. For example, instructions tothe doctor as to how to carry out testing by opening any flaps and/ortabs on second panel may be provided.

In a further embodiment, panel 4 can be provided with indicating meansfor locating where specimen is to be placed on the sheet. The indicatingmeans may comprise printed circles or other shapes on the panel as avisible indicator to the user of where to place the specimen.

FIG. 5 shows the absorbent sheet 500 according to an alternateembodiment of the device of the invention suitable for use with thepanel 4 of the prior embodiment. Sheet 500 includes test areas 502, 504and 506. Each test area 502, 504 and 506 of Sheet 500 contains twoperforated zones, one corresponding to each of the secondary sampleapertures: test area 502 contains perforated zones 520 and 522; testarea 504 contains perforated zones 524 and 526; and test area 506contains perforated zones 528 and 530. Each perforate zone 520, 522,524, 526, 528 and 530 is adhered to a corresponding tab 540, 542, 544,546, 548 and 550, respectively. In other words, each perforated zone isbacked by the tab—another layer, such as paper, cardboard, plastic orother material—which extends beyond the bottom edge where the firstpanel meets the second panel, through a corresponding opening or slot.Each tab can be used to pull the corresponding perforated zone frombetween the panels to be used for the secondary test procedure (e.g.,immunochemistry test). As such, in this embodiment, there is no need forany tabs in the secondary test areas of the second panel; instead, thesample can be removed from the device simply by pulling the appropriatepull-tab. In alternate embodiments, the pull tab may comprise alengthened section of the sheet without any backing

FIG. 6 a and FIG. 6 b show a second panel 600 with test areas 602, 604and 606 according to another embodiment of the invention. Although notshown, the present embodiment uses a front panel as shown in FIG. 2 Assuch, flaps 608, 610, 612 are aligned with primary sample apertures inthe front panel for opening during the primary test procedure.Furthermore, each circular (although other shapes may be used) tab 650,652, 654, 656, 658 and 660 is aligned with a corresponding aperture onthe front panel 670 for a secondary specimen. There are correspondingapertures in panel 600 located opposite of the secondary specimenapertures of the front panel 670, which apertures are covered bycircular tabs 650, 652, 654, 656, 658 and 660. The circular tabs areremovably adhered to the rear or outside surface of panel 600 via anadhesive located along all or part of the circumference or edge of eachtab. In this embodiment, there is no sheet located between the panels inthe secondary test area, however, the center of each tab 650, 652, 654,656, 658, 666 includes a piece of the sheet adhered thereto forreceiving the secondary sample, although the sheet is not required.

As shown in the sectional view of FIG. 6 b, the aperture 662 in panel600 is covered by tab 650, which includes a piece of sheet 664 alignedwith the aperture 662. The center of the circular tabs receive thesecondary specimen through the secondary apertures of panel 670 andapertures 662 of panel 600. The circular tabs and their correspondingspecimens can be removed from the device by peeling them off of thedevice. In certain embodiments, the tabs are dimensioned to fit within atest tube or other container used with a secondary, specific testprocedure.

With regard to the embodiment of FIGS. 1-4, where a fecal sample is tobe analyzed, the device 2 is typically sent home with a patient. Thepatient opens the cover 40 on the first panel 4 of the device and smearsa first fecal specimen through one primary aperture 10 and also throughthe corresponding secondary aperture 22, thereby depositing samples onthe exposed sheet 8. In the present embodiment, a primary sampleaperture and a secondary sample aperture are identified through markingson the first panel, namely, for receiving sample from the same area orregion of the bowel movement being tested. A second fecal specimen, forexample, taken at a different time as a result of a different bowelmovement or from a different region of the same bowel movement as thefirst specimen, is then smeared through other corresponding primary 12and secondary sample 24 apertures, onto the exposed sheet 8. With thesamples taken, the cover 40 is closed and secured in the arcuate slit34. It should be noted that each of the secondary samples taken isreceived (or deposited on), at least partially, by a correspondingperforated zone. In embodiments where the sheet 8 does not extend to theregion corresponding to the secondary sample apertures, the secondarysample is received by a portion of the corresponding tab.

The patient obtains the requisite number of samples and typically eitherreturns the device to the physician or to a laboratory.

To conduct a primary (e.g., non-specific) analysis, the flap 74 onsecond panel 6 covering the primary aperture wells of the first testarea 100 in which the specimens have been applied, is opened anddeveloper solution is applied to the exposed sheet 8.

Typically, if both primary specimens test negative, no further testingis required, thereby saving the cost of a secondary analysis. If aprimary specimen tests positive, a secondary analysis can be performed.More specifically, to perform a secondary analysis, the tab (by way ofexample, 62) corresponding to the “positive” primary sample aperture(e.g., 10) is opened, thereby tearing the corresponding perforated zone(e.g., 120) away from sheet 8. The perforated zone 120 carrying thesecondary sample is removed from device 2 by tearing the tab 62 from thesecond panel 6. The tab 62, along with the perforated zone 120, isplaced in a container or tube for secondary analysis. In the presentembodiment, the secondary analysis is an immunochemical test, which hasfewer false positives than the primary test, the guaiac test. As such,because the secondary sample corresponds to the positive primary sample(e.g., is preferably a portion of the same specimen as the primaryspecimen) the secondary analysis can facilitate confirmation of thepositive primary test or indicate that the primary test was a falsepositive, thereby combining the sensitivity of the primary test with thespecificity of the secondary test.

In the alternate embodiment of FIG. 5, once the primary analysis hasbeen performed, as above, and a positive result is obtained, a secondaryanalysis is similarly performed by pulling the pull-tab corresponding tothe positive primary sample from the device and placing the pull-tab,along with the secondary sample, in a container or otherwise using itfor further testing.

Various alternate embodiments in which the removable tab is placed onthe first panel and in which the aperture for receiving the primarysample is the same aperture used for receiving a secondary sample willnow be described with reference to FIGS. 7 a-c. It should be appreciatedthat by using the same aperture or well for both the primary andsecondary specimen, portions of the same specimen (i.e., a sample fromthe same region of a bowel movement) is used in both the primary andcorresponding secondary test procedures. This is beneficial given thetendency of the blood to be dispersed (if present) non-uniformly througha bowel movement. As an initial matter, it is to be understood thatalthough a single test area is shown in each figure, multiple test areasmay be combined into a single device.

Turning first to FIG. 7 a, there is shown a device 700 having two wells702, 704 for receiving samples. Although not shown, the device 700 isconstructed generally as the embodiment of FIG. 4, having a sheet 706between a first panel 710 and a second panel (not shown). Apertures inthe first panel 710 define the wells 702, 704.

Each well 702, 704 is partially covered by a tab 712 in the form of astrip, such as a metal, plastic, wax coated, impervious paper or othermaterial. The tab 712 is removable, either by using removable adhesiveto attach it to the first panel 710 or, as in FIG. 7 b, by usingperforations other means allowing the tab to be torn away.

In use, a patient smears a specimen in a well 702, thus causing thesample to be placed on the sheet 706 as well as on the tab 712.Accordingly, the well 702 includes areas both containing the specimen714, as well as areas without the specimen 716. Notably, the primaryspecimen on the sheet 706 and secondary specimen on the tab arenecessarily from the same smear.

When performing the primary test procedures, the physician or laboratoryproceeds generally as described above, by opening a flap on the rear ofthe device and applying developing solution. In the event the primarytest is positive, the tab 712 may be removed and used in connection asecondary testing procedure. The tab 712 may be removed prior todepositing the developing solution, (for example, to help preventcontamination). Additionally, the tab 712 extends beyond the aperture,thereby providing a means for easy removal, without contamination of thesample.

In certain embodiments in which the primary sample and secondary sampleare obtained in the same well with a tab covering a portion of the well(as in FIGS. 7 a-c), it is possible to apply the developing solution inconnection with the primary test directly to the front of the device,through the aperture in the first panel. In such embodiments, the tab ortabs are first removed, thereby exposing areas of the sheet with andwithout the specimen. Because the tab or tabs provide a metering effect(as also shown in FIGS. 7 b and 7 c), controlling the amount of specimenin the well and on the sheet, the physician or laboratory is able toread the results of the test without the need for a flap on the rear ofthe device. Even where a rear flap is used, the metering effect isdesirable, as the test results are easier to read.

Moreover, it should be understood that the tab or even non-removablecovering may be used to meter the amount of specimen in any of theembodiments described herein. In certain embodiments the metering coveris integrally formed with the first panel and is not removable, servingonly a metering purpose and not as a means for collecting a secondaryspecimen.

In other alternate embodiments, the tab may not be placed on the firstpanel, but may be placed under it, between the first panel and thesheet.

In the embodiment of FIG. 7 b, the device 720 similarly includes twowells 722, 724, each for receiving both primary and secondary samples.In the present embodiment, however, rather than using a tab formed of astrip adhered to the surface of the first panel, the present tabs 726,728 are formed by punching out portions of the first panel 730.Preferably, each tab 726, 728 includes an extension 726 a, 728 a orother portion extending away from the area receiving the specimen,thereby providing the tester an area for grasping the tab 726, 728 foreasy removal without contaminating the specimen.

As shown in connection with the first well 722, in which the tab 726 isin an open position, placing the sample in the well 722 results in apattern on the sheet 732 of areas with specimen 734 and areas withoutthe specimen 736. Again, a single smear results in both the primary andsecondary specimens, thereby ensuring the two specimens are taken fromthe same portion of a sample. Indeed, the secondary specimen is actuallya portion of the primary specimen.

In use, the primary test may be performed either by opening a flap onthe rear of the device 720, and depositing the developing solution inthe well 722, 724, either before or after removing the tab 726, 728.Alternatively, the tab 726, 728 can be opened and developing solutionplaced directly in the well 722, 724. Upon a positive primary specimen,the corresponding tab 726, 728 may be used in connection with asecondary test to confirm a positive result or to identify a falsepositive result.

FIG. 7 c illustrates another exemplary embodiment in which the same well(and smear) is used for both the primary and secondary samples and,accordingly in which specimens from the same portion of a bowel movementare used for both the primary and secondary test procedures. Morespecifically, the device 740 includes two wells 742, 744. Prior to use,each well 742, 744 is covered with a tab 746 with a plurality ofopenings, which is adhered to the surface of the first panel 748 byremovable adhesive. (Well 742 is shown after use, with the correspondingtab removed.) In the present embodiment, the tab 746 is wider than thewell 744 to provide an area without specimen for grasping. In otherembodiments, the tab can include an extension for ease of grasping.

In use, the patient smears the specimen in the wells 742, 744 across thetabs 746, thereby depositing some specimen in the well on sheet 750 andsome specimen on the tab 746. As shown in the first well 742, in whichthe tab has been removed, the tab meters the amount of specimen in thewell 742, thus resulting in a pattern of areas both with 752 and without754 specimen.

As with the embodiments of FIGS. 7 a and 7 b, the primary test proceduremay be carried out via a flap on the back of the device 740 or bydepositing developing solution directly into the well after removing thecorresponding tab. Because the tab provides a metering function, theresults of a the primary test may be read without the need for the flapon the rear. In the event the primary test is positive, thecorresponding tab may be used to perform the secondary test procedure.

According to an additional embodiment, the testing device may beprovided individually or may be packaged in kit form. For example, kitsmight be prepared comprising numerous testing devices, reagents requiredto perform the primary analysis for such devices, such as the developingsolution used in the guaiac test, sample tubes in which to place thetabs and perforated zones from the sheet and materials for a secondarytest, such as, but not limited to, a specific immunochemical test, suchas an ELISA, Lateral Flow Device, or any testing procedure used forhuman blood.

The test tubes may be pre-filled with the test reagents or they may beprovided separately. To reduce costs, the kit may contain fewerimmunochemical test reagents than primary test reagents given the use ofthe immunochemical test in a confirmatory role.

In an alternate embodiment, the device functions as a device forobtaining samples, independent of actual testing. The device 860generally includes three sample areas 812, 814, 816 and is formed of afirst panel 862 and a second panel 864. As illustrated in the embodimentin FIG. 8, the panels 862, 864 and covers 800, 802, 804, can be formedof a single sheet of paper, cardboard or other suitable material, inwhich the apertures, slits, tabs and perforations are die-cut. Thedevice 860 is assembled by folding the sheet along line A-A and lineB-B, thereby overlaying panel 862 on to panel 864 and the covers 800,802, 804 on to first panel 862. The assembly is held together with asuitable glue or adhesive. It should be understood that panels 862 and864 may be constructed separately and then assembled (e.g., glued alonga portion of the edges) to form the device.

Each sample area 812, 814, 816 is configured to receive samples throughthree apertures, which can be situated transversely, or parallel to orat any angle relative to the longitudinal axis L. The apertures in eachsample area 806, 808, 810 are preferably positioned along a straightline to facilitate insertion of a single tab 820, 822, 824 carrying thesamples into a test tube or other testing device; however, the alignmentof the apertures and, thus, the shape of the tabs, may be changed tosuit the particular tests or uses to be carried out on the samples. Inthe present embodiment, the apertures are situated such that they areslightly off-center in their respective test area. This is to ensureproper placement of the sample onto a portion of a removable tab inorder to prevent contamination of the sample.

The first test area 812 includes three apertures 840, 842, 844 in panel862 for receiving samples. Similarly, the second test area 814 includesapertures 846, 848, 850, and the third test area 816 includes apertures852, 854, 856. According to the present embodiment, the shapes of theapertures on panel 862 can include, but are not limited to an oval,circle, square, rectangle or other shape. Furthermore, while threeapertures per area 806, 808, 810 are preferred for receiving threesamples from each bowel movement, fewer or greater than three aperturescan be used. For example, in one embodiment, two rows of multipleapertures per area is used.

Each of the three areas 812, 814, 816 also has a cover 800, 802, 804,respectively, thereto along a fold line A-A extending parallel to thelongitudinal axis L. Each cover 800, 802, 804 is engageable with acorresponding flap formed by arcuate slit 830, 832, 834, respectively,which is used to maintain the covers in a closed position, after thesamples are obtained.

As shown in FIG. 8, second panel 864 includes three test areas 806, 808,810 and further includes removable perforated tabs 820, 822, 824,respectively, each of which aligns with the corresponding apertures onpanel 862. More specifically, test area 806 includes perforated tab 820aligned with apertures 840, 842, 844; in test area 808, tab 822 alignswith apertures 846, 848, 850; and in test area 810, tab 824 aligns withapertures 852, 854, 856.

The portion of the tab that does not come into contact with thespecimen, which is made relatively larger due to the apertures beingpositioned off-center (e.g., 826); is used to pull the tab (e.g., 820)away from the device. In this way, physical contact between the testerand the specimen is prevented, thereby decreasing the chance ofcontamination of the specimen.

The covers 800, 802, 804 for first panel 862 may be provided withappropriate printed matter to assist the patient, physician and/orlaboratory. For example, the patient's name, address and instructions onhow to use the device may be printed on the covers 800, 802, 804. Suchinstructions may include instructing the patient to apply a specimenfrom the same areas of the fecal matter, or even the same smear, in eachof the sample wells. Printed matter may also be provided on the secondpanel 864. For example, instructions to the tester as to how to removethe pull tabs 820, 822, 824 such that the fecal sample is removed fromthe device.

In a further embodiment, panel 862 can be provided with indicating meansfor locating where specimen is to be placed on the sheet. The indicatingmeans may comprise printed circles or other shapes on the panel as avisible indicator to the user of where to place the specimen.

With regard to the embodiment of FIG. 8, where a fecal sample is to beacquired, the device 860 is typically sent home with a patient. Thepatient opens the cover 800 on the first panel 862 of the device andsmears a first fecal specimen from an area of the bowel movement throughone aperture 840 in test area 812, a second fecal specimen from an areaof the bowel movement through second aperture 842 in test area 812, anda third fecal specimen from an area of the bowel movement through secondaperture 844 in test area 812, thereby depositing samples on theperforated tab 820, which is aligned with apertures 840, 842, 844. Ifdesired, a second fecal specimen, for example, taken at a different timeas a result of a different bowel movement or from a different region ofthe same bowel movement as the first specimen, is then smeared throughother apertures 846, 848, 850 in test area 814 and onto the perforatedtab 822. With the samples taken, the cover 800 is closed and secured inthe arcuate slit 830.

The patient obtains the requisite number of samples and typically eitherreturns the device to the physician or to a laboratory. Once the patienthas returned the sampling device to the appropriate personnel theacquired samples can be tested for the presence of fecal occult bloodusing any of the tests described herein.

Embodiments of the present invention enjoy numerous advantages. Forexample, the device can be embodied in one card which readilyfacilitates transference between the doctor and the patient and betweenthe doctor and another testing location, such as a laboratory. Thedevice is easy to use by the patient and is inexpensive to produce. Onefurther advantage is that the device allows a first test to be carriedout and, in the event that a specimen is positive, subsequent testingcan be carried out on a separate portion of the same specimen. Inaddition, the device is such that it reduces the possibility ofcontamination of the secondary sample when being removed from thedevice.

Those skilled in the art will recognize that the method and system ofthe present invention has many applications, may be implemented in manymanners and, as such, is not to be limited by the foregoing exemplaryembodiments and examples. In this regard, any number of the features ofthe different embodiments described herein may be combined into onesingle embodiment, and all features of a given embodiment need not beincluded in other embodiments. Moreover, the scope of the presentinvention covers conventionally known and future developed variationsand modifications to the components and materials described herein, aswould be understood by those skilled in the art.

For example, in the above description, the apertures, perforated zonesand tabs are illustrated as rectangular or circular. However, anydesired shape may be used, for example, oval, square, rectangular orother polygon.

In the above description, the tabs are illustrated as being perforatedon three sides. However, the tabs may also be perforated on fewer sides,(e.g., two sides, with a cut-out along, one side) or on all sides and bepunched out of the device for use in the secondary analysis of thespecimens. Tabs may also be oriented in different directions.

Furthermore, although embodiments are shown with three test areas fortesting three bowel movements, with two or three samples or specimensfrom each, other numbers of samples/specimens may be taken.

The embodiments of the invention has been described with reference toanalysis of fecal samples for stool occult blood. However, the devicemay be used for screening and testing of other biological specimens, forexample blood and AIDS tests, urine tests and pregnancy tests.

While the present invention has been described in considerable detail,the invention disclosed herein is not limited to the detaileddescription, and is to be afforded the full scope of the appended claimsand all equivalents thereto.

The invention claimed is:
 1. A collection device not having a reagentimpregnated sheet and for use only in connection with off-device testingof collected samples, the device consisting essentially of: a firstpanel having one or more apertures each defining a well for receiving asample; a second panel opposite the first panel; and a removable tab,the movable tab being accessible from an exterior of the device, the tabhaving a first portion and a second portion; wherein the first portionis aligned with at least one of the apertures on the first panel andconstructed such that depositing the sample through the at least oneaperture causes the sample to be directly deposited on the first portionof the tab to be made available for use in an off-device testingprocedure which is performed once the removable tab is removed from thetesting device; and wherein the second portion is not aligned with anyof the apertures on the first panel and is constructed such thatdepositing the sample through any of the apertures on the first paneldoes not deposit the sample on the second portion, the second portioncomprising a sample-free grasping area for removing the tab.
 2. Thedevice of claim 1 wherein the removable tab is substantially linear. 3.The device of claim 1 further comprising multiple removable tabs,wherein the multiple apertures are in multiple rows, each row ofapertures opposite a separate one of the multiple removable tabs.
 4. Amethod of collecting a fecal sample consisting essentially of: providinga collection device not having a reagent impregnated sheet and for useonly in connection with off-device testing of collected samples, thecollection device comprising a first panel and a second panel forming asecond exterior surface of the device opposite the first panel, thefirst panel having one or more apertures therein defining one or morecollection wells and being opposite the second panel, a removable tabhaving a sample-carrying area aligned with at least one aperture on thefirst panel and a sample-free area not aligned with any of the apertureson the first panel, the sample-free area being accessible from anexterior of the device; receiving the collection device having thesample, the sample directly deposited through at least one of theapertures onto the sample-carrying area of the movable tab; removing theremovable tab from the collection device by pulling the sample-free areathereby collecting the sample; and after removing the removable tab,testing, off-device, the sample deposited on the sample-carrying area.5. The method of claim 4 wherein the collection device has multiplesamples deposited through the multiple apertures.
 6. The method of claim5 wherein the device further comprises multiple portions of the secondpanel and multiple apertures in multiple rows and wherein applying thesamples comprises applying a separate sample through each row ofapertures onto a separate one of the multiple portions of the secondpanel.
 7. A collection device for use only in connection with off-devicetesting of collected samples, the device comprising: a first panelhaving one or more apertures for receiving samples; a second panelopposite the first panel; and a removable tab accessible from anexterior of the device, the tab having a first portion and a secondportion; wherein the first portion is aligned with at least one of theapertures on the first panel and constructed such that depositing thesample through the at least one aperture causes the sample to bedirectly deposited on the first portion of the tab to be made availablefor use in an off-device testing procedure which is performed once theremovable tab is removed from the collection device; and wherein thesecond portion is not aligned with any of the apertures on the firstpanel and is constructed such that depositing the sample through theapertures on the first panel does not deposit the sample on the secondportion, the second portion comprising a sample-free grasping areaaccessible from the exterior of the device for removing the tab.
 8. Thecollection device of claim 7, wherein removing the removable tab carriesthe sample with it.